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Omnaris Versus Levocetirizine Phase 4 Study

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ciclesonide
Levocetirizine
Ciclesonide & Levocetirizine
Sponsored by
Handok Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring efficacy, ciclesonide, levocetirizine, allergic rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
  • Moderate to severe patient according to ARIA guideline
  • To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
  • Subjects who complete the subject diary(S) at least 70%.

Exclusion Criteria:

  • Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
  • Hypersensitivity to corticosteroid and/or hydroxyzine
  • Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
  • A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
  • Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
  • Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)

Sites / Locations

  • handok pharmaceuticals co. LTD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ciclesonide nasal spray

Levocetirizine

Ciclesonide nasal spray & Levocetirizine

Arm Description

ciclesonide nasal spray, alone

Levocetirizine, alone

Ciclesonide nasal spray & Levocetirizine in combination

Outcomes

Primary Outcome Measures

rTNSS
change from baseline in the average of AM and PM patient assessed reflective TNSS

Secondary Outcome Measures

rTOSS
Reflective total ocular symptom sores
TNSS
Patient assessed individual TNSS
PANS
Physician-assessed overall nasal signs and symptoms severity (PANS)
RQLQ
Rhinoconjunctivitis quality of life questionnaire (RQLQ)

Full Information

First Posted
September 6, 2011
Last Updated
September 5, 2012
Sponsor
Handok Inc.
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01430260
Brief Title
Omnaris Versus Levocetirizine Phase 4 Study
Official Title
A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Handok Inc.
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
Detailed Description
randomized, open-label, three arm, parallel group, multi-center study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
efficacy, ciclesonide, levocetirizine, allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ciclesonide nasal spray
Arm Type
Experimental
Arm Description
ciclesonide nasal spray, alone
Arm Title
Levocetirizine
Arm Type
Active Comparator
Arm Description
Levocetirizine, alone
Arm Title
Ciclesonide nasal spray & Levocetirizine
Arm Type
Active Comparator
Arm Description
Ciclesonide nasal spray & Levocetirizine in combination
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Other Intervention Name(s)
Omnaris
Intervention Description
200 ㎍ once daily
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Other Intervention Name(s)
XYZAL
Intervention Description
5mg once daily
Intervention Type
Drug
Intervention Name(s)
Ciclesonide & Levocetirizine
Other Intervention Name(s)
Omnaris nasal spray, XYZAL
Intervention Description
Omnaris (ciclesonide) 200 ㎍ once daily Levocetirizine 5mg once daily
Primary Outcome Measure Information:
Title
rTNSS
Description
change from baseline in the average of AM and PM patient assessed reflective TNSS
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
rTOSS
Description
Reflective total ocular symptom sores
Time Frame
2 weeks
Title
TNSS
Description
Patient assessed individual TNSS
Time Frame
2 weeks
Title
PANS
Description
Physician-assessed overall nasal signs and symptoms severity (PANS)
Time Frame
2 weeks
Title
RQLQ
Description
Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer) Moderate to severe patient according to ARIA guideline To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen. Subjects who complete the subject diary(S) at least 70%. Exclusion Criteria: Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment Hypersensitivity to corticosteroid and/or hydroxyzine Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moonhwa Park, Doctor
Organizational Affiliation
Handok Inc.
Official's Role
Study Director
Facility Information:
Facility Name
handok pharmaceuticals co. LTD
City
Seoul
ZIP/Postal Code
135-755
Country
Korea, Republic of

12. IPD Sharing Statement

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Omnaris Versus Levocetirizine Phase 4 Study

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